MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	TW*DS418FH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved runthrough device was used during the procedure and separated on withdrawal.The patient's condition was reported good and was doing fine.The procedure outcome was good.The estimated blood loss was less than 250cc.There was no patient injury, medical/surgical intervention required.Additional information was received on 10jun2020.There was no part left in the patient.The procedure being performed was a coronary angioplasty.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10189414
• Report Number: 2243441-2020-00034
• Device Sequence Number: 14261311
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: 04987350720986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020
• Report Date (Section F): 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: TW*DS418FH
• Device Catalogue Number: 25-3011
• Device Lot Number: 190809
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/09/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 06/24/2020